Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

Study Description

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Brief Summary:

Cardiac arrest or sustained VT (ventricular tachycardia) in patients with heart disease is best treated with an ICD (implantable cardioverter defibrillator). However, the ICD alone is not appropriate therapy for patients with frequent VT episodes. In fact frequent shocks for VT may predict a poorer prognosis. Anti-arrhythmic drugs are co-administered with ICDs in up to 50% of patients to prevent VT episodes, but antiarrhythmic drugs may have harmful effects. Thus improved drugs to prevent VT without interfering with ICD function are needed. Recent data including our own suggest that clonidine may be a new therapy to prevent ICD shocks. It may act centrally on sympathetic outflow and peripherally and selectively on cardiac Purkinje, to suppress and control VT occurring in patients. Our purpose is to test the hypothesis that clonidine reduces frequent VT better than beta blocker in patients with ICDs. After informed consent patients will be randomized in a single blind fashion to either clonidine or metoprolol given three times per day. Other prescribed drugs may be adjusted to promote toleration of the study drug. ICD interrogations of episodes of VT will be the primary endpoint. Device based NIPS (non-invasive programmed stimulation) testing in a subset of these patients will allow mechanistic understanding of the clonidine effect. All of the procedural techniques are in place as performed clinically; preliminary data are given showing feasibility of the project.

Condition or disease	Intervention/treatment	Phase
Ventricular Tachycardia	Drug: clonidine; Drug: metoprolol	Not Applicable

Detailed Description:

we had wanted very commonly occurring VT episodes on ICD interrogation: 5 episodes/ 3 months. We could not enroll more than 2 patients most of which have interventions to prevent episodes. Thus we could not enroll patients and discontinued the study in the first year.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
Actual Study Start Date :	May 2006
Actual Primary Completion Date :	January 2012
Actual Study Completion Date :	January 2012

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Clonidine therapy group; clonidine 0.1 TID	Drug: clonidine; 0.1 mg tid
Active Comparator: Metoprolol control group; metoprolol 25 TID	Drug: metoprolol; 25 mg tid

Outcome Measures

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Primary Outcome Measures :

1. episodes of non-sustained ventricular tachycardia [ Time Frame: one year ]

Secondary Outcome Measures :

1. defibrillator shocks [ Time Frame: one year ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Implantable defibrillator treated patients with 5 episodes of ventricular tachycardia per 3 month period

Exclusion Criteria:

• No more than one shock/3 months
• No contraindication to clonidine
• Non-compliance
• Asthma

Contacts and Locations

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Locations

United States, Iowa
UIHC
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

James Martins

National Center for Research Resources (NCRR)

Investigators

Principal Investigator:	james b martins, md	University of Iowa

More Information

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Responsible Party:	James Martins, Professor, University of Iowa
ClinicalTrials.gov Identifier:	NCT00585871 History of Changes
Other Study ID Numbers:	200602703; study is over no ID is needed
First Posted:	January 3, 2008
Last Update Posted:	July 24, 2018
Last Verified:	July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by James Martins, University of Iowa:

ICD patients with 5 VTs per 3 month period

Additional relevant MeSH terms:

Clonidine; Tachycardia; Tachycardia, Ventricular; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Metoprolol; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antihypertensive Agents	Sympatholytics; Autonomic Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Adrenergic beta-1 Receptor Antagonists; Adrenergic beta-Antagonists; Adrenergic Antagonists